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Recall Observatory FDA recall evidence

Device product

Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT

Z-0177-2026

September 04, 2025

Class II

Product summary

Firm
American Contract Systems Inc.
Event
Event 97659
Status
Ongoing
Classification
Class II
Quantity
32,433 total
Official record key
device-enforcement:Z-0177-2026

Official wording

Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Code information: UICL44P UDI-DI 191072194268 Lot 8003911 Bag serial number N/A; UICL44R UDI-DI 191072234018 Lot 8317711 Bag serial number 68244081 * If bag serial number is listed as "n/a", then entire lot is affected

Distribution pattern: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.